FDA 510(k) Clearances - March 2026
283 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
March 2026 overview
The FDA cleared 283 medical devices in March 2026 through the 510(k) premarket notification pathway. This compares to 215 clearances in February 2026 - an increase of 68 (+31.6%).
Orthopedic led all specialties with 55 cleared devices. The fastest average review was Hematology at 30 days. The slowest was Anesthesiology at 218 days.
Overall average review time: 140 days, ranging from 1 to 706 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - March 2026
Detailed data
Review time in calendar days from FDA receipt to decision. Source: FDA 510(k) downloadable files.
| Specialty | Cleared | Avg days | Min | Max | vs February |
|---|---|---|---|---|---|
| Orthopedic | 55 | 119 | 23 | 276 | +13 |
| Radiology | 52 | 142 | 15 | 269 | +24 |
| General & Plastic Surgery | 33 | 117 | 19 | 268 | -3 |
| Dental | 23 | 133 | 1 | 300 | +14 |
| Cardiovascular | 21 | 172 | 28 | 706 | -8 |
| Neurology | 20 | 133 | 28 | 252 | +12 |
| Gastroenterology & Urology | 16 | 144 | 27 | 372 | +7 |
| Physical Medicine | 12 | 130 | 29 | 259 | +6 |
| General Hospital | 9 | 214 | 120 | 273 | -5 |
| Anesthesiology | 8 | 218 | 86 | 293 | +4 |
| Microbiology | 8 | 95 | 14 | 263 | +5 |
| Obstetrics & Gynecology | 8 | 186 | 27 | 337 | -1 |
| Ear, Nose, Throat | 6 | 130 | 52 | 262 | +2 |
| Ophthalmic | 6 | 178 | 79 | 270 | +3 |
| Chemistry | 3 | 207 | 108 | 257 | -5 |
| Toxicology | 2 | 73 | 34 | 112 | +1 |
| Hematology | 1 | 30 | 30 | 30 | - |
| Total | 283 | 140 | 1 | 706 | +68 |
Key observations
Fastest reviews
The fastest individual clearance took 1 day. Reviews under 5 days typically reflect Special 510(k) submissions for minor modifications to already-cleared devices.
Longest review
The longest individual review reached 706 days. Extended reviews typically indicate additional information requests or complex predicate device questions. The FDA's standard target is 90 days from receipt.
Leading specialty: Orthopedic
Orthopedic led March 2026 with 55 clearances - 19% of all monthly clearances.
Review time spread
Anesthesiology posted the highest average at 218 days. Hematology was fastest at 30 days. The gap of 188 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in March 2026 were Arthrex, Inc. (6) , Canon Medical Systems Corporation (3) , Medtronic Navigation, Inc. (3) , Synthes GmbH (3) and Philips Healthcare (Suzhou) Co., Ltd. (2) . Together, these five manufacturers accounted for 17 of the 283 total clearances - 6% of all March activity.
About this data
This report covers FDA 510(k) submissions with a decision date in March 2026 and a valid days-to-decision value. Data is sourced from the FDA 510(k) public files, published on the 5th of each month and in the public domain (17 U.S.C. § 105). Only cleared decisions are counted (SESE, SESK, SESU, SEKD, SESP, SESD, ST, SN).
Maintained by Space Bits, S.L. Not affiliated with or endorsed by the FDA. Verify at accessdata.fda.gov.